Post on 01-Apr-2023
MREC Protecting Human Research
Subjects
Institutional Review Board (IRB) / Independent Ethics
Committee (IEC)
MREC Protecting Human
Research Subjects
IRB/IEC Defined
MGCP 1.37
Institutional Review Board (IRB) or Independent Ethics
Committee (IEC)
An independent body constituted of medical, scientific, and
non-scientific members, whose responsibility is to ensure the
protection of the rights, safety and well-being of human subjects
involved in a trial by, among other things, reviewing, approving,
and providing continuing review of trial protocol and amendments
and of the methods and material to be used in obtaining and
documenting informed consent of the trial subjects.
MREC Protecting Human
Research Subjects
What are the Responsibilities of the IRB/IEC?
MGCP 3.1.1
An IRB/IEC should safeguard the rights, safety and
well-being of all trial subjects. Special attention should be
paid to trials that may include vulnerable subjects.
MREC Protecting Human
Research Subjects
How does the IRB/IEC Carry out its
Responsibilities?
MGCP 3.1.2
The IRB/IEC reviews the following documents: trial
protocol(s)/amendment(s), written informed consent form(s)
and consent form updates, subject recruitment procedures (e.g.
advertisements), written information to be provided to subjects,
investigator’s brochure, safety information, information about
payments and compensation, investigator’s curriculum vitae,
and any other necessary documents.
MREC Protecting Human
Research Subjects
How does the IRB/IEC carry out its
Responsibilities?
MGCP 3.1.2 (Cont…)
The IRB/IEC should review a proposed clinical trial
within a reasonable time and document its views in writing,
clearly identifying the trial, the documents reviewedand the
dates for its decision on approval
MREC Protecting Human
Research Subjects
How often should an IRB/IEC Monitor an
Approved Trial?
MGCP 3.1.4
The IRB/IEC should conduct continuing
review of each ongoing trial at intervals appropriate
to the degree of risk to human subjects, but at least
once a year.
MREC Protecting Human
Research Subjects
Can The IRB/IEC Request Additional
Information To Be Included In The Informed
Consent Documents For A Trial?
MREC Protecting Human
Research Subjects
Can the IRB/IEC request additional
information to be included in the informed
consent documents for a trial?
MGCP 3.1.5
The IRB/IEC may request more information
to be given to subjects when, in the judgment of the
IRB/IEC, the additional information would add
meaningfully to the protection of the rights, safety
and well-being of the subjects.
MREC Protecting Human
Research Subjects
What Is The Responsibility Of The IRB/IEC In
Non-therapeutic Trials Where Consent Is From A
Legally Acceptable Representative?
MREC Protecting Human
Research Subjects
MGCP 3.1.6
Where a non-therapeutic trial is to be carried out
with the consent of the subject’s LAR, the IRB/IEC should
determine that the proposed protocol and /or other
documents adequately addresses relevant ethical concerns
and meets applicable regulatory requirements for such
trials.
Responsibility Of The IRB/IEC In Non-therapeutic Trials
Where Consent Is From A Legally Acceptable
Representative.
MREC Protecting Human
Research Subjects
What Is The Responsibility Of The IRB/IEC In
Situations Where Consent From A Subject Or The
Subject’s Legally Acceptable Representative Is Not
Possible?
MREC Protecting Human
Research Subjects
MGCP 3.1.7
The IRB/IEC should determine that the proposed
protocol and/or other documents adequately addresses
relevant ethical concerns and meets applicable regulatory
requirements for such trials.
What Is The Responsibility Of The IRB/IEC In Situations
Where Consent From A Subject Or The Subject’s Legally
Acceptable Representative Is Not Possible?
MREC Protecting Human
Research Subjects
How does the IRB/IEC review payments or
compensation to subjects?
MREC Protecting Human
Research Subjects
MGCP 3.1.8
The IRB/IEC should review the amount and method
of payment to assure that neither presents problems of
coercion or undue influence on the trial subjects. Payment
should be prorated and not wholly contingent on
completion of the trial by the subjects.
How Does The IRB/IEC Review Payments Or
Compensation To Subjects?
MREC Protecting Human
Research Subjects
How does the IRB/IEC review payments or
compensation to subjects? (cont.)
MGCP 3.1.9
The IRB/IEC should ensure that information
regarding payments to subjects, including the methods,
amounts, and the schedule of payment, is set forth in the
written informed consent form. The way payment will be
prorated should be specified.
MREC Protecting Human
Research Subjects
What is the recommended composition of an
IRB/IEC?
MGCP 3.2.1
The IRB/IEC should consist of a reasonable number of
members who collectively have the qualifications and experience to
review and evaluate the science, medical aspects, and ethics of the
proposed trial. It is recommended that the IRB/IEC should include:
a)At least 5 members
b)At least one member whose primary area of interest is in a non-
scientific area
c)At least one member who is independent of the institution/trial
site.
MREC Protecting Human
Research Subjects
What is the composition of an IRB/IEC?
MGCP 3.2.1 (cont.)
Only members who are independent of the
investigator and the sponsor of the trial should
vote/provide opinion on a trial-related matter.
A list of IRB/IEC members and their qualifications
should be maintained.
MREC Protecting Human
Research Subjects
How Does An IRB/IEC Makes Its Decision
On Approval Of A Trial?
MREC Protecting Human
Research Subjects
How does an IRB/IEC makes its decision on
approval of a trial?
MGCP 3.2.3
The IRB/IEC should make its decisions at
announced meetings at which at least a quorum, as
stipulated in its written SOP, is present.
MGCP 3.2.4
Only members who participate in the review and
discussion should vote/provide their opinion and/or advice
MREC Protecting Human
Research Subjects
How does an IRB/IEC makes its decision on
approval of a trial? (cont.)
MGCP 3.2.5
The investigator may provide information on any
aspects of the trial, but should not participate in the
deliberations or in the vote/opinion of the IRB/IEC.
MGCP 3.2.6
An IRB/IEC may invite non-members with expertise
in special areas for assistance.
MREC Protecting Human
Research Subjects
If An Institution Does Not Have An IRB/IEC, Can
The Institution Use Another Institution’s
IRB/IEC?
MREC Protecting Human
Research Subjects
If an institution does not have an IRB/IEC,
can the institution use another institution’s
IRB/IEC?
MGCP 3.2.7
An institution without IRB/IEC may request
IRB/IEC of Ministry of Health, Malaysia, to make
decisions on behalf of the said institution.
MREC Protecting Human
Research Subjects
What information should be in the SOPs of
an IRB/IEC?
MGCP 3.3
The composition (names and qualifications of members),
and the authority under which it is established.
Scheduling, notifying its members of, and conducting tis
meetings.
Conducting initial and continuing review of trials.
Determining frequency of continuing review, as
appropriate.
MREC Protecting Human
Research Subjects
What information should be in the SOPs of
an IRB/IEC? (cont.)
MGCP 3.3
Providing expedited review and approval/favourable
opinion of minor change(s) in ongoing trials that have
the approval/favourable opinion of the IRB/IEC.
Specifying that no subject should be admitted to a trial
before IRB/IEC issues its written approval/favourable
opinion of the trial.
MREC Protecting Human
Research Subjects
What information should be in the SOPs of
an IRB/IEC? (cont.)
MGCP 3.3
Specifying that no deviations from, or changes of, the protocol
should be initiated without prior written IRB/IEC
approval/favourable opinion of an appropriate amendment,
except :
a)when necessary to eliminate immediate hazards to
subjects, or
a)When the changes involve only logistic or administrative
aspects of trial
MREC Protecting Human
Research Subjects
What information should be in the SOPs of
an IRB/IEC? (cont.)
MGCP 3.3
Specifying that the investigator should promptly report to
IRB/IEC:
Deviations from, or changes of, the protocol to eliminate
immediate hazards to trial subjects.
Changes increasing risk to subjects and/or affecting
significantly the conduct of the trial.
All adverse drug reactions that are both serious and
unexpected.
New information that may adversely affect safety of subjects
or conduct of trial.
MREC Protecting Human
Research Subjects
What information should be in the SOPs of
an IRB/IEC? (cont.)
MGCP 3.3
Ensure that IRB/IEC promptly notify in writing, in
investigator concerning:
a)Its trial-related decisions/opinions.
b)The reasons for its decisions/opinions.
c)Procedures for appeal of its decisions/opinions.
32
MREC Protecting Human
Research Subjects
How Long Should An IRB/IEC Retains Its
Records?
MGCP 3.4
IRBIEC should retain all relevant records (e.g. written
procedures, membership lists, lists of occupations/affiliations of
members, submitted documents, minutes of meetings, and
correspondence) for a period of at least 3 years after completion
of the trial and make them available upon request from the
regulatory authority.
The IRB/IEC may be asked by investigators, sponsors or
regulatory authorities to provide its written procedures and
membership lists. 34
MREC Protecting Human
Research Subjects
MREC Website
Refer to website for specific
MREC requirements for ethical
approval.
www.nih.gov.my/mrec
35